U.S. patent application number 09/742635 was filed with the patent office on 2002-06-27 for implant device and dosage form employable therein.
Invention is credited to Bardani, Frank M..
Application Number | 20020082565 09/742635 |
Document ID | / |
Family ID | 24985633 |
Filed Date | 2002-06-27 |
United States Patent
Application |
20020082565 |
Kind Code |
A1 |
Bardani, Frank M. |
June 27, 2002 |
Implant device and dosage form employable therein
Abstract
An implant device comprises a tubular member having a bore, a
charging end and a pointed elongated annular concavely beveled
implanting end. A rod is removably insertable within the bore for
delivery of an implant dosage form charged within the bore. A stop
member for hindering movement of the rod sufficiently to prevent
unintentional delivery of the implant dosage form but not
sufficient to prevent same when delivery is intended is mounted on
the tubular member. A truncated cylindrical solid shaped implant
dosage form having an ellipsoidal face is positioned in the bore at
the implanting end in alignment with same so that a substantially
continuous elipsoidal surface is presented.
Inventors: |
Bardani, Frank M.;
(Purchase, NY) |
Correspondence
Address: |
MORTON S. SIMON ESQ
3 ROSELAND COURT
NEW CITY
NY
10956
US
|
Family ID: |
24985633 |
Appl. No.: |
09/742635 |
Filed: |
December 22, 2000 |
Current U.S.
Class: |
604/239 |
Current CPC
Class: |
A61M 37/0069
20130101 |
Class at
Publication: |
604/239 |
International
Class: |
A61M 005/00; A61M
005/31 |
Claims
What is claimed is:
1. An implant device comprising: (a) a tubular member having a
central longitudinal axial bore therethrough, a pointed elongated
annular concavely beveled implanting end and a charging end for
inserting an implant dosage form in the bore; (b) a rod having an
implanting end and at its opposite end a head, the head being
affixed to the rod and having a diameter greater than that of the
rod, the difference in the diameter of the head and the diameter of
the rod defining a shoulder, the rod being removably insertable in
the bore of the tubular member and slidably moveable therein along
the longitudinal axis of the tubular member toward the implanting
end for delivery of an implant dosage form contained in the bore;
and (c) a stop member on the tubular member for hindering movement
of the rod toward the implanting end sufficiently to prevent
unintentional delivery of an implant dosage form when it is present
within the bore but not sufficient to prevent such movement when
the delivery is intended.
2. The device as claimed in claim 1, wherein the stop member is
mounted at the charging end of the tubular member and in contact
with the rod.
3. The device as claimed in claim 1, further including at least one
solid implant dosage form in said bore.
4. The device as claimed in claim 3, wherein the implant dosage
form in the bore and adjacent to the implanting end has an
ellipsoidal face that is in alignment with the pointed annular
concavely beveled implanting end so as to present a complimentary
substantially continuous ellipsoidal surface.
5. The device as claimed in claim 4, wherein the implant dosage
form in the bore and adjacent to the implanting end has a
cylindrical body having a substantially flat bottom and a top that
angles downward from a first point at the top of the cylindrical
body to a second point on the cylindrical body opposite to the
first point and closer to the bottom than the first point so that
the top of the cylindrical body is truncated whereby said
ellipsoidal face is produced.
6. The device as claimed in claim 1, wherein prior to use of the
device to deliver one or more implant dosage forms contained within
the bore, the stop member is mounted in part on the rod and in part
on the tubular member at the charging end.
7. The device as claimed in claim 1, wherein, after use of the
device to deliver one or more implant dosage forms contained within
the bore, the stop member is mounted on the tubular member at the
charging end and in contact with the shoulder.
8. The device as claimed in claim 1, wherein the stop means is
frictionally mounted on the tubular member and when sufficient
force is applied to the head of the rod to overcome frictional
resistance of the stop member and move the rod in the bore toward
the implanting end a sufficient distance to eject an implant dosage
form from the bore, is moveable from a first position at which the
stop member is mounted partly on the tubular member at the charging
end and partly on the rod to a second position at which the stop
member is mounted on the tubular member at the charging end and in
contact with the shoulder.
9. The device as claimed in claim 3, further including means for
preventing the implant dosage form charged within the bore from
exiting the bore prior to use of the device.
10. The device as claimed in claim 9, wherein the means for
preventing comprises an adhesive in the bore and in contact with
the implant dosage form and the bore wall at the implanting
end.
11. The device as claimed in claim 9, wherein the means for
preventing comprises a boss on the wall of the bore adjacent the
implanting end and in contact with the implant dosage form at the
implanting end.
12. A shaped solid implant dosage form comprising a cylindrical
body having a substantially flat bottom and a top that angles
downward from a first point at the top of the cylindrical body to a
second point on the cylindrical body opposite the first point and
closer to the bottom than the first point so that the top of the
cylindrical body is truncated and has an ellipsoidal face.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an improved device for the
administration of drugs. More particularly, the invention relates
to an improved device for subcutaneous introduction of drug
implants and to a novel shaped implant dosage form for use in such
device.
BACKGROUND OF THE INVENTION
[0002] Techniques and devices for introducing solid medicaments
beneath the skin are known in the art. Medical use of drug implants
was initiated as early as 1861, see Howard Jones, N., J. Hist. Med.
2, 201 (1947).
[0003] Implants have advantageously been used for administration of
hormones, such as testosterone, estradiol and other drugs, where
slow, constant release and continuous absorption of a drug over
prolonged time periods is desired. The long lasting effect of a
drug implant frees the patient from the need to take multiple
periodic parenteral or oral doses. In the long run, implant therapy
is often more economical. Moreover, where a dosage regimen is
critical, use of implants eliminates the possibility of missed
doses. Though clinical use of pellet implants has declined with the
development of oral dosage forms, it nevertheless remains a
valuable medical tool in, for example, drug absorption studies.
Surface area of an implant is readily determined and controlled.
Moreover, the effective area of a pellet in contact with body
tissues can be measured, before and after implantation, by simple
direct inspection of the implant.
[0004] As stated heretofore, devices for subcutaneous introduction
of implants are disclosed in the prior art. One such device
comprises an injector needle, having a central longitudinal axial
bore and a sharp beveled end, a first plunger having a sharp
beveled end and a second plunger having a blunt end. The first
plunger and the second plunger are each removably insertable within
the bore of the injector needle. The technique employed with this
prior art device is as follows:
[0005] The area wherein the pellet is to be inserted is
anesthetized with a local anesthetic. A small incision is made in
the skin to permit free passage of the injector needle. The first
plunger is inserted into the bore of the injector needle, then the
injector needle, with the first plunger in place, is inserted into
the subcutaneous tissue. When insertion of the injector needle is
complete the first plunger is withdrawn from the bore. A drug
pellet is then introduced into the injector bore and gently forced
down the bore and into the subcutaneous tissues with the blunt end
of the second plunger. Once the pellet is fully inserted, the
injector and the second plunger seated in the bore are
simultaneously withdrawn. The incision is then closed with sutures,
a clip, or an adhesive bridge etc.
[0006] The aforementioned prior art device suffers from several
major defects and has not proven successful. Firstly, a preliminary
surgical incision is required before the device can be employed.
Secondly, if upon insertion into the subcutaneous tissues, the
injector needle, with the first plunger in place, is not properly
oriented, that is to say, the beveled sharp end of the first
plunger is not in alignment with the beveled sharp end of the
injector needle, insertion of the device will result in
considerable tearing of the tissues.
[0007] U.S. Pat. No. 3,921,632 discloses an improvement over the
above-described prior art device. Use of such improved device
obviates the need for preliminary surgical incision. The device of
such patent makes a clean incision. No stitching or sutures are
generally thereafter required. Furthermore, in the device of such
patent, means are provided for preventing improper orientation of
the sharp end of the injector needle and the sharp end of the first
plunger so that disadvantageous tearing of the skin and tissues is
avoided.
[0008] The device of U.S. Pat. No. 3,921,632 comprises: a tubular
member having a central longitudinal axial bore therethrough, a
pointed elongated annular concavely beveled implanting end and a
charging end. The implanting and charging ends communicate with the
bore. A first plunger having a solid pointed elongated annular
concavely beveled end is adapted to be removably inserted in the
bore for slidable movement therein. When the first plunger is
completely inserted in the bore of the tubular member the beveled
implanting end of the tubular member and the beveled end of the
first plunger are aligned to form a complimentary substantially
continuous, pointed, elongated, annular concavely beveled
penetration surface. The first plunger is slidably moveable in the
bore of the tubular member from a first to a second position at
which insertion of the plunger in the bore is complete. Means are
also provided for permitting the alignment at only the second
position. As is shown in FIG. 4 of the patent, a second plunger
having a blunt tip is also provided. The device of U.S. Pat. No.
3,921,632 works as follows:
[0009] As is seen from FIG. 1 of the patent, the first plunger 6 is
introduced into the bore of the tubular member and when fully
introduced the ends (elements 9, 3, and 10) are in alignment. This
is more clearly shown in FIG. 2 of the patent. The cannula of the
device is then injected into the patient. After it is introduced
the first plunger is slidably removed from the bore and a pellet
implant is inserted into the bore. The blunt ended plunger is then
employed to push the pellet through the bore and into the
subcutaneous tissues of the patient.
SUMMARY OF THE INVENTION
[0010] The present invention presents improvements on the
above-described device of U.S. Pat. No. 3,921,632.
[0011] The implant device of the present invention can
advantageously be made of metal, such as stainless steel, or of
plastic and stainless steel and can be sterilized by steam or
radiation. Most desirably, with the exception of the cannula, all
parts are made of plastic so that the device is less costly and
disposable.
[0012] A further advantage of the improved device of the present
invention is that it contains fewer parts than the device of U.S.
Pat. No. 3,921,632. There is no need for the blunt plunger 16 of
such patent. Moreover, the device of the present invention can be
preloaded with one or more pellet implants. This is possible
because of the novel form of the solid dosage form of the present
implant device.
[0013] As will be more fully described later on in this disclosure,
the present invention provides a solid implant dosage form that is
shaped so that when it is in the bore of the injector needle and
positioned at its end, a face of the solid dosage form aligns with
the beveled end of the injector needle so as to present a
complimentary elongated annular concave surface
DESCRIPTION OF THE DRAWINGS
[0014] The present invention will now be described in greater
detail with reference to the accompanying drawings in which like
elements are assigned the same numerical designation.
[0015] In the drawings:
[0016] FIG. 1 is a plan view of a preferred embodiment of an
implant device in accordance with the present invention, partly in
section and showing delivery of two implant dosage forms;
[0017] FIG. 2 is plan view of the implant device of FIG. 1, partly
in section, showing the device preloaded and prior to use;
[0018] FIG. 3 is a partial top view of the implanting end of the
tubular member of the device of FIGS. 1 and 2, showing an implant
in the bore of the tubular member;
[0019] FIG. 4 is a side view of the novel shaped implant dosage
form of the invention that is positioned in the bore of the tubular
member adjacent the end of same as is shown in FIG. 2;
[0020] FIG. 5 is a side view of a cross section of the end of the
preloaded device of FIG. 2 showing adhesive means for preventing
the shaped implant from prematurely exiting the bore of the tubular
member; and
[0021] FIG. 6 shows an alternative means of retaining the shaped
implant dosage form within the bore of the tubular member until
such time the device is injected subcutaneously to deliver the
implant dosage form(s).
DETAILED DESCRIPTION OF THE INVENTION
[0022] Referring now to FIG. 1: Injector cannula or tubular member
1 has a longitudinal axial bore 2 therethrough, a pointed elongated
annular concavely beveled implanting end 3 and a charging or inlet
end 4. Bore 2 communicates with implanting end 3 and with inlet end
4. A finger hold 5, which can also serve as insertion limiting stop
member, is mounted on tubular member 1.
[0023] Finger hold 5 can be hourglass shaped so as to provide a
convenient gripping surface for the fingers. Finger hold 5 can be
fixed in position on or unitary with tubular member 1.
Alternatively, finger hold 5 can be adjustable in position along
the longitudinal axis of tubular member 1 so as to permit
regulation of the maximum depth of penetration of implanting end 3
into the subcutaneous tissues. Adjustability of the position of
finger hold 5 on tubular member 1 can be attained by providing
finger hold 5 with releasable friction gripping means. For example,
finger hold 5 can have a bore that has internal threading. A
setscrew having external complementary threading is positioned
within the bore. The set screw can be threaded downwards and into
contact with the outer surface of tubular member 1 to frictionally
engage same and fix the position of finger hold 5 thereon.
Alternatively, finger hold 5 can be internally threaded and tubular
member 1 can have complimentary external threading that permit
finger hold 5 to be threaded towards or away from implanting end 3.
Means for enabling adjustability of the position of finger hold 5
on tubular member 1 are disclosed in U.S. Pat. No. 3,921,632 and
are incorporated herein by reference.
[0024] As illustrated in FIGS. 1 and 2, a plunger 6, comprised of a
solid rod portion 7, a head portion 8, the difference between the
diameter of the rod portion 7 and the head portion 8 defining a
shoulder 19, and a blunt end 9 is removably insertable in bore 2 of
tubular member 1 for slidable movement therein along the
longitudinal axis of tubular member 1.
[0025] As more fully shown in FIG. 3, implanting end 3 of tubular
member 1 is beveled and pointed in order to facilitate penetration
into the subcutaneous tissues for delivery of one or more implant
dosage forms.
[0026] As shown in FIGS. 1 and 2, the device of the present
invention can be preloaded with one or more implant dosage forms.
The implant dosage forms are loaded into bore 2 at charging or
inlet end 4. To facilitate introduction of the implant dosage
form(s) into bore 2, inlet end 4 can be configured as described in
U.S. Pat. No. 3,921,632. Plunger 6 is then introduced into bore 2
and slid downwardly therein, until blunt end 9 is in contact with
the pellet(s) within bore 2.
[0027] Preferably, as shown in FIGS. 1 and 2, a stop member 10 is
mounted on tubular member 1. Stop member 10 functions to hinder
downward movement of plunger 6 into the bore 2. The resistance
provided by stop member 10 should be sufficient to prevent
unintentional ejection of the implant dosage form(s) contained in
bore 2. It should not, however, be so high as to prevent an
intentional downward movement of plunger 6 when the device is used
to inject the implant dosage form(s). Basically, the stop member 10
functions to prevent accidental premature delivery of the implant
dosage form(s) from the device.
[0028] As seen in FIG. 2, prior to use of the preloaded device, the
stop member 10 is preferably mounted on the tubular member at the
inlet end 4 and in contact with rod 7. Alternatively, stop member
10 can be mounted on rod 7 and in contact with inlet end 4 of
tubular member 1.
[0029] As is shown in the preferred embodiment of FIGS. 1 and 2,
stop member 10 frictionally engages both tubular member 1 and rod
7.
[0030] FIG. 2 shows the preferred embodiment of the device of the
present invention prior to use. Stop member 10 is adapted to
provide sufficient frictional resistance against downward movement
of rod 7 within bore 2 towards implanting end 3 so as to prevent
unintentional delivery of the implant dosage form(s). The
frictional resistance provided by stop member 10 should be such as
to be readily overcome when the device is intentionally used to
subcutaneously deliver its preloaded implant dosage form(s).
[0031] FIG. 1 shows the device of the invention after it has been
employed to subcutaneously deliver the implant dosage forms. It
should be noted that rod 7 is fully inserted in bore 2 and stop
member 10 is positioned on tubular member 1 and only in contact
with shoulder 19 of head portion 8 of plunger 6.
[0032] Stop member 10 can be a rubber or plastic ring
circumferentially mounted on the tubular member 1. Stop member 10
is preferably frictionally fit on tubular member 1 so that
slideable motion of the plunger 6 into bore 2 occurs only when
sufficient force is applied to head portion 8 to overcome the
frictional resistance.
[0033] As noted earlier, when preloaded with one or more implant
dosage forms and fitted as shown in FIG. 1, the device of the
present invention can be packaged and sterilized by methods well
known to those skilled in the art.
[0034] As shown in FIGS. 1, 2, 3 and 4, the solid implant dosage
form 11, positioned in bore 2 adjacent to the pointed elongated
annular concavely beveled implanting end 3, is substantially wedge
shaped at one end. Shaped implant 11 has a pointed elongated
annular concave beveled face 12 which aligns with the pointed
beveled implanting end 3 of the tubular member 1 when the shaped
implant dosage form 11 is within bore 2 and adjacent to pointed
implanting end 3. When so positioned within bore 2, face 12 and the
pointed elongated annular concave beveled implanting end 3 are
aligned. Preferably, the alignment produces a substantially
continuous surface, which substantially prevents tearing of tissue
when the device is employed to inject the implant dosage form(s).
More specifically, when face 12 and implanting end 3 are aligned
apexes 12a and 12b are respectively aligned with apexes 3a and 3b
of implanting end 3 so as to present a complimentary elongated
annular concave surface.
[0035] The novel implant dosage form 11 of the present invention is
preferably cylindrical in shape. As is shown in FIG. 4, implant
dosage form 11 has a cylindrical body 13 having a substantially
flat bottom 14 and an angularly truncated top portion 15 which
slopes downwards from a first point 15a, at an apex at the top of
the cylinder wall, to a second point 15b, on the cylinder wall
opposite to and closer to bottom 14 and lower than first point 15a.
Ellipsoidal face 12 extends between the first and second points.
Thus the novel implant dosage form 13 of the instant invention has
a substantially wedge shaped top and a substantially flat
bottom.
[0036] If more than one implant dosage form is to be injected, only
the implant dosage form that is within bore 2 and adjacent end 3
must have an elongated annular concave face 12 as heretofore
described. In other words, the first implant dosage form within the
bore 2 and adjacent implanting end 3 must be the shaped implant
dosage form 11. Other implant dosage form(s) 16 positioned in bore
2 upstream from shaped implant dosage form 11 can possess any
convenient shape consistent with the shape of the bore 2 and blunt
end 9 of rod 7.
[0037] The diameter of the cylindrical implant dosage form of the
present invention is limited by the inside diameter of the bore 2
of tubular member 1. Generally, the implant dosage form of the
invention has a diameter of from about {fraction (1/32)} inch to
about 1/4 inch and a length of from about {fraction (1/8)}-inch to
about 2 inches.
[0038] It should be appreciated that when more than one implant
dosage form is to be injected each can contain the same medication,
in the same or different dose or release rate. The implant dosage
forms can also differ in the medication(s) they contain and in the
dose or release rate of each such medication.
[0039] When the implant device of the present invention is
preloaded with one or more implant dosage form(s), means can be
employed to keep the implant(s) in place within bore 2 of tubular
member 1. FIGS. 5 and 6 show preferred embodiments of such
means.
[0040] As shown in FIG. 5 an adhesive 17, preferably a soluble
adhesive that is FDA approved for internal use, e.g. PVP, is
employed to hold implant dosage form 11 within bore 2 of tubular
member 1. The adhesive attachment should be readily overcome by
downward force of plunger 6 when the device is used to inject the
implant dosage form(s).
[0041] FIG. 6 shows an alternative means for keeping the implant
dosage form(s) within bore 2 of tubular member 1. A boss 18 is
provided on the inner wall of bore 2 of tubular member 1. Boss 18
contacts shaped implant dosage form 11 and provides sufficient
resistance to keep the shaped implant dosage form 11 within bore 2
and in alignment with pointed elongated annular concavely beveled
implanting end 3 thereby preventing it from being delivered until
the device is used. The contact should be such as to be readily
overcome by the downward force of plunger 6 when the device is used
to inject the implant dosage form(s).
[0042] Other means for keeping the implant dosage form(s) in place
within bore 2 of tubular member 1, until such time as the device is
used, should be obvious to one skilled in the art. For example, a
removable plastic tip can be fitted over the implanting end 3 of
tubular member 1 so as to encase same and keep the implant dosage
form(s) within bore 2. The tip can be removed immediately before
the device is employed to inject the implant dosage form(s)
contained therein.
[0043] The contents of all patents, patent applications, published
articles, books, reference manuals and abstracts cited herein are
hereby incorporated by reference in their entirety to more fully
describe the state of the art to which the invention pertains.
[0044] As various changes can be made in the above-described
subject matter without departing from the scope and spirit of the
invention, it is intended that all subject matter contained in the
above description, shown in the accompanying drawings, or defined
in the appended claims, be interpreted as descriptive and
illustrative, and not in a limiting sense. Many modifications and
variations of the present invention are possible in light of the
above teachings. It is therefore to be understood that within the
scope of the appended claims, the invention may be practiced
otherwise than as specifically described.
* * * * *